Educational Intervention for Management of Constipation

Constipation Clinical Trial

— DEMCON  

Official title:

Developing an Testing an Educational Intervention for the Management of Constipation for People With Advanced Cancer: a Feasibility Intervention Study (DEMCON)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04501263
• Other study ID #: 18NI0074
• Secondary ID: MCCC-RP-16-A2099
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: August 2020
• Source: University of Ulster
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The overall aim of the study is to develop and test the feasibility and acceptability of a novel educational intervention for HCPs to help them manage constipation experienced by people in the hospice setting. This stage aims to establish the feasibility of, and to pilot, a novel educational intervention for HCPs. Additionally, it also originally aimed to test the feasibility of the chosen measures of change in patient care, however this was not undertaken. In order to achieve this aim, the objectives are to:

• Implement the educational intervention across Marie Curie sites.

• Evaluate the likely effectiveness of the educational intervention on the knowledge and self-efficacy of HCPs.

• Explore the feasibility and acceptability of the educational intervention with HCPs, and identify factors associated with feasibility/acceptability

• Explore the feasibility and acceptability of research procedures, and identify factors associated with feasibility/acceptability

• Examine the effect of contextual factors upon the implementation and sustainability of the educational intervention in the hospice.

• Examine the suitability of outcome measures for HCPs

Description:

An incremental, multi-method approach was adopted, in line with the MRC Framework for complex interventions. Four prior data collection phases helped to inform the development of the educational intervention (a review of guidelines and a systematic review of the existing literature Muldrew et al 2018; a clinical case note review (McIlfatrick et al 2019) and qualitative findings from patients, caregivers and health professionals (Hasson et al 2019). The refinement of the intervention involved the project's fourth step (unpublished). This was the use of the Nominal Group Technique (NGT) with 39 HCPs to help identify priorities in the assessment and management of constipation. The findings from the NGT were further ratified by an international review group (n=19) on constipation management and care.

A mixed methods approach was undertaken to inform the development of the intervention and assess its impact. A small cohort, one-sample repeated measures design was used to assess the impact of the intervention on the knowledge of participants (health care professionals). Data collection was focused on three primary groups of HCPs; nurses, medics, and pharmacists. Qualitative data were collected after the intervention to assess the appropriateness of the intervention, the support in the specialist palliative care unit to complete it, the overall processes surrounding its implementation, and any impact that participants felt it had on practice. These data were gathered from focus groups (n=4) with 14 HCPs and nine telephone interviews with managers and senior staff in the SPC units. The intervention was delivered, and participants were recruited from five specialist palliative care inpatient units in the UK (Northern Ireland, Scotland, and England).

HCPS (nurses, medics, pharmacists) were invited to participate if they met the following inclusion criteria; (i) working in a clinical capacity in the SPC inpatient unit; (ii) involvement in the management of patients with constipation; (iii) over 18 years of age; and (iv) able to provide written consent in English. The educational intervention was advertised across sites through Research Leads, flyers and the identification of a "champion", in conjunction with senior staff. HCPs who met the inclusion criteria and were willing to participate could sign up via a webpage containing an information sheet, consent form, and information on how to access the education programme.

Intervention development and implementation processes Based on the findings from the previous stages, a 6-week, online, educational program was created with Syngery Learning an online learning management company, on constipation assessment and management. Each week of the program consisted of a short theoretical introduction to key aspects of constipation (assessment, prevention, non-pharmacological management, pharmacological management, opioid induced constipation, and bowel obstruction). This was supplemented with a quiz, link to practice activity, and a group discussion in an online closed group. Participant's study was largely self-directed and flexible. They could log in at any time during the 6-week data collection period to complete the activities. Managers of the specialist palliative care units were supportive of the educational program and assisted in the practical elements of running the course, including releasing staff from their workload to complete the required activities. Participants were encouraged to complete these activities during their work hours.

Data collection Measures were completed online at baseline and after completion of the educational intervention. Competency measures were the primary outcome of the study, linked to the NiCan Framework for Generalist and Specialist Palliative and End of Life Care Knowledge and Skills Framework. Participants completed a competency assessment tool extracted from the Competency and End of Life Care Competency Tool and the Knowledge and Self-Efficacy Survey. The intervention was implemented gradually, over two separate occasions, enabling learning from the first phase to be incorporated into the second phase.

Qualitative Data Collection Qualitative data were collected after the intervention to assess the appropriateness of the resource, the support within the SPC unit to complete it, the overall processes surrounding its implementation, and any impact that participants felt it had on practice. This used focus groups and telephone interviews with managers and senior staff within the specialist palliative care units . Participants taking part in were invited to participate if they met set inclusion criteria; (i) employed by hospice as HCP; (ii) previous experience working with patients receiving palliative care who suffer from constipation; (iii) over 18 years of age; and (iv) Willing to participant in the study and have provided informed consent.

Cost analysis Information was collected on the time spent by staff on the training resource, by staff type and by study centre. Staff time was valued using unit costs obtained from the Personal Social Services Research Unit Costs of Health & Social Care 2018.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: March 31, 2020
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Working in a clinical capacity in the SPC inpatient unit

• Involvement in the management of patients with constipation.

• Over 18 years of age;

• Able to provide written consent in English.

Exclusion Criteria:

• Anyone who did not meet the above criteria.

Related Conditions & MeSH terms

• Constipation

Intervention

Behavioral:
• DEMCoN Educational Intervention
Educational programme on constipation for Health care professionals in this clinical specialist palliative care

Locations

Country	Name	City	State
United Kingdom	Ulster University	Newtownabbey	Antrim

Sponsors (4)

Lead Sponsor	Collaborator
University of Ulster	Marie Curie Hospice, Belfast, Queen's University, Belfast, University of Bristol

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

Hasson F, Muldrew D, Carduff E, Finucane A, Graham-Wisener L, Larkin P, Mccorry N, Slater P, McIlfatrick S. 'Take more laxatives was their answer to everything': A qualitative exploration of the patient, carer and healthcare professional experience of constipation in specialist palliative care. Palliat Med. 2020 Sep;34(8):1057-1066. doi: 10.1177/0269216319891584. Epub 2019 Dec 23. — View Citation

McIlfatrick S, Muldrew DHL, Beck E, Carduff E, Clarke M, Finucane A, Graham-Wisener L, Larkin P, McCorry NK, Slater P, Hasson F. Examining constipation assessment and management of patients with advanced cancer receiving specialist palliative care: a multi-site retrospective case note review of clinical practice. BMC Palliat Care. 2019 Jul 15;18(1):57. doi: 10.1186/s12904-019-0436-3. — View Citation

Muldrew DHL, Hasson F, Carduff E, Clarke M, Coast J, Finucane A, Graham L, Larkin P, McCorry NK, Slater P, Watson M, Wright E, McIlfatrick S. Assessment and management of constipation for patients receiving palliative care in specialist palliative care settings: A systematic review of the literature. Palliat Med. 2018 May;32(5):930-938. doi: 10.1177/0269216317752515. Epub 2018 Feb 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study specific questionnaire	To evaluate the feasibility of delivering an educational intervention in a specialist palliative care setting	October 2018- January 2019
Primary	Study specific questionnaire	To evaluate the acceptability of delivering an educational intervention in a specialist palliative care setting	October-2018-January 2019
Secondary	Knowledge and self-efficacy survey	To evaluate the impact of the intervention on the knowledge of participants	October 2018-January 2019
Secondary	Focus group and telephone interviews	To explore managers and staffs views on the appropriateness of the resource, the support to complete it and process surrounding implementation and any perceived impact on practice.	October 2018- January 2019
Secondary	Personal Social Services Research Unit Costs of Health and Social Care	To assess the resources used in the intervention on the knowledge of participants Assess the costs associated with providing the intervention	October 2018-January 2019
Secondary	Competency and end of life care competency tool	To evaluate the impact of the intervention on the knowledge (competency) of participants	October 2018-January 2019